A Multicenter Clinical Trial of Urine DNA Testing for Bladder Cancer in China

NCT05337189 | Recruiting

• 1 other identifier: KLM2021-04
• Study Type: observational
• Target: 482
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the safety and effectiveness of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) for help diagnose bladder cancer by comparing with clinical standard method (includes medical imaging (MRI, CT, etc.), cystoscopy, pathological examination).

Conditions

Bladder Cancer; Urocystitis; Urinary Bladder Stone; Urothelial Carcinoma

Keywords

Bladder Cancer; Urine DNA Test; Gene Methylation Biomarkers; Multigene Methylation Detection; Cancer Screening; Urothelial Carcinoma

Outcome Measures

Primary Outcomes (4)

• Sensitivity

  Sensitivity is the percentage of subjects with lung cancer who are correctly identified by the testing kit.

  One year

• Specificity

  Specificity is the percentage of subjects without lung cancer who are correctly excluded by the testing kit.

  One year

• Consistency Rate

  Consistency rate is the fraction of both true positive and negative diagnostic test results among all subjects.

  One year

• Kappa Coefficient

  Kappa coefficient is the consistency analysis of the extent of agreement between the test results of the testing kit and standard method.

  One year

Study Arms (2)

Bladder cancer group

Two groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting urine specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) test, eligible subjects also need to undergo the examination of standard method.

Diagnostic Test: Urine DNA methylation analysis; Procedure: medical imaging and/or cystoscopy and/or pathological examination

The normal group

Two groups of sequential enrolled subjects, eligible subjects will be included in the study according to the inclusion criteria. In addition to collecting urine specimen for the testing kit of Human Multigene Methylation Detection Kit (Fluorescent PCR Method) test, eligible subjects also need to undergo the examination of standard method.

Diagnostic Test: Urine DNA methylation analysis; Procedure: medical imaging and/or cystoscopy and/or pathological examination

Interventions

Urine DNA methylation analysis DIAGNOSTIC_TEST

Urine specimen will be collected by the subject for the detection of Human Multigene Methylation Detection Kit (Fluorescent PCR Method)

Also known as: URISAFE

Bladder cancer group; The normal group

medical imaging and/or cystoscopy and/or pathological examination PROCEDURE

Subjects will undergo medical imaging and/or cystoscopy and/or pathological examination

Bladder cancer group; The normal group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects without age limit, regardless of gender or region, and those who meet the inclusion criteria for this clinical trial, are eligible to enroll at the designated clinical sites. 482 subjects are targeted to enroll.

You may qualify if:

• Subject must meet all three of the following criteria to be eligible for the study:
• Who without age and gender limit, and is participating voluntarily and willing to sign Informed Consent Form;
• Who is willing to undergo or has completed medical imaging and/or cystoscopy and/or pathological examination;
• Any subject who is required to meet any of the following conditions:
• Who is diagnosed with or suspected of bladder cancer.
• Who has high risk factors for bladder cancer (such as engaged in contact with aromatic amines, dyes, rubber, aluminum, leather and other occupations, schistosomiasis infection, family genetic history, smoking, drinking, etc.).
• Who has hematuria symptoms (such as cystitis, stones, etc.).
• Who has other diseases that can be easily confused with bladder cancer.

You may not qualify if:

• Subject with any of the following conditions shall be excluded:
• Who has undergone surgery or chemoradiotherapy.
• Who has other conditions that the investigator considers inappropriate to participate in this clinical trial.

Sponsors & Collaborators

• Creative Biosciences (Guangzhou) Co., Ltd.: lead
• Guangzhou Xiangkang Medical Research Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Cystitis; Urinary Bladder Calculi; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Urinary Calculi; Urolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Peng Du, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianshu Wang, PhD

CONTACT

86-01-18819269978; xianshuwang@creativebio.cn

Chunhua Chen

CONTACT

86-01-13560141654; chenchunhua@creativebio.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 20, 2022
• Study Start: March 9, 2022
• Primary Completion: April 15, 2025
• Study Completion: April 30, 2025
• Last Updated: February 13, 2025

Record last verified: 2024-06

Locations

CN (1)